Is it Really just a Wording Problem

…or is there more to the story? Animal feed and Pet Food Industry groups are asking members of Congress to push FDA to make administrative changes to law. On the surface, this ‘push’ is reported as simply a wording problem in the Food and Drug Administration Amendments Act of 2007 (FDAAA). The wording in question: pet food ingredient standards and pet food ingredient definitions. This is a puzzle; what is actually going on and why?

Pieces of the puzzle…

The animal feed news website FeedStuffs.com on July 18, 2013 published “The feed and pet food industry are urging members of Congress to sign onto a letter circulated by Reps. Andy Barr (R., Kent.) and Bob Latta (R., Ohio) to the Food and Drug Administration (FDA) asking them to administratively resolve an issue emanating from the Food & Drug Administration Act Amendments of 2007 (FDAAA).”

“Following new rules implemented in the wake of the China melamine pet food incident, FDA’s interchangeable uses of “definition” and “standards” with regard to the development of pet food ingredient standards is now being questioned. The use of both terms in FDAAA – only “definition” is used in the Food, Drug & Cosmetic Act – has caused some at FDA to question the existing FDA and Center for Veterinary Medicine (CVM) ingredient approval process, and may jeopardize FDA’s 35-year formal relationship with the Association of American Feed Control Officials (AAFCO), which represents state feed regulators.”

“As these issues have been in regulatory limbo for so long, companies developing new animal feed and pet food ingredients are currently withholding their applications for approval until the system is certain. This loss of innovation hurts feed and pet food companies, farmers and ranchers, and ultimately, consumers,” the letter states.”

This makes little sense. Seriously? Two little words – definitions and standards – could cause the end of AAFCO and cause losses to the feed and pet food industries? So what is this “regulatory limbo” mentioned in this (mysterious) letter?

After the 2007 pet food recall, Congress required FDA improve the safety of pet food (the full three sections of the law in reference to pet food are quoted at the end of this article). Congress included in FDAAA laws a requirement that FDA must establish pet food ingredient definitions, pet food processing standards, and update pet food labels so they include nutritional and ingredient information. Congress required FDA complete this task “not later than 2 years after the date of the enactment of this Act” – which would mean these pet food ingredient definitions, processing standards and updated label requirements should have been completed by September 2009.

But they have not been completed; to date (July 2013) this task has not been completed by FDA. Since it has not been completed, the story quoted above (from FeedStuffs.com) makes a little sense but…could it really be true that the whole reason FDA has not completed this task ordered by Congress is because of two little words?

What does that letter say?

This was/is all very puzzling. Why now? Why is the pet food industry encouraging members of Congress – some six years after the law was written – to nudge FDA to alter the law? I needed to read the letter.

A phone call to Representative Andy Barr’s office in Washington (listed as one of the names in support of this letter) resulted in no information. Rob of Representative Barr’s office is trying to find more information for me and promised to be back in touch.

A call to Representative Bob Latta’s office in Washington (the other name listed in the FeedStuffs.com article as co-author of the letter) led me to Mandi who told me the letter hasn’t been completed yet; they are still working on it. She explained that those two words – standard and definition – were the reason that FDA has not met the 2009 deadline to define pet food ingredients, establish pet food processing standards, and update labeling requirements. She shared that FDA has asked Congress to ‘fix’ the two words legislatively and that Congress is now (at the request of industry groups) asking FDA to ‘fix’ the two words administratively.

I asked “Did FDA tell you this? Is there information confirming this on the FDA website? Was there a letter or something that FDA sent to Congress stating that these two words were the reason nothing has been accomplished on FDAAA with pet food?”

She answered – “no, this is what we were told by the industry groups.” (Hmmmm, something smells a little fishy.) Mandi asked if I opposed the letter. I told her I have no idea if I agree or disagree with it – I’ll need to read it first. She stated she would provide me a copy of the letter when it is completed.

This still just doesn’t add up. A little searching on the FDA website led me to a November 2012 letter from AAFCO to FDA on the same subject – pet food ingredient standards/definitions. Significant quotes from this letter…

“With the adoption of FDAAA into law, the term “ingredient standard” was not defined and has caused confusion in the ingredient review process, which may result in the current process being eliminated by FDA. In order to define “ingredient standard” and keep the process operating for the benefit of the agency, AAFCO and the regulated industry, AAFCO supports efforts by the American Feed Industry Association and other organizations to provide a “technical legislative fix” (see attached) to the federal Food, Drug and Cosmetic Act that would, in essence, adopt the AAFCO OP Feed Ingredient Definitions into federal law making those definitions legal for FDA’s purposes.”

“AAFCO strongly supports this legislative effort and urges your support as well. Otherwise, the development and introduction of new feed ingredients to the marketplace will become even more burdensome and likely jeopardize AAFCO’s production of its OP.”

Two clues. One…if FDA develops pet food ingredient definitions, a huge income opportunity for AAFCO would be diminished. The AAFCO Official Publication includes all pet food ingredient definitions (and is the ONLY source for those definitions); the cost of the 2013 book is $90.00. If FDA authors pet food ingredient definitions, they would be published on the FDA website and few would have a need to purchase the $90.00 AAFCO publication. AAFCO would lose income.

Clue number two…The AAFCO letter specifically mentions the American Feed Industry Association (AFIA). This organization has a strong influence at AAFCO meetings. I’ve witnessed on numerous occasions AAFCO members allowing an AFIA representative to respond to a regulatory question (a question that should have been answered only by a regulatory authority). In other words, it has been my experience AFIA controls a great deal of what happens at AAFCO meetings. The Pet Food Institute (PFI – lobby organization for big pet food) is right along side of AFIA in controlling the pet food regulatory process (and I would have to guess is who “other organizations” mentioned in the AAFCO letter are).

The perfect example of this was at the January 2013 meeting in Albuquerque, NM when members of AFIA and PFI were provided a 45 minute presentation to bash Right to Know efforts (right to know if a food/pet food contained genetically modified ingredients). This was a regulatory meeting, not a debate setting or personal opinion setting. But just because it was an official pet food/animal feed regulatory meeting, it didn’t stop authorities from providing industry with 45 minutes of opportunity to voice industry opinion.

So…again…what is really going on? Next, I wrote FDA…

It has been brought to our attention there has been a request from members of Congress (specifically Representative Andy Barr and Representative Bob Latta) for FDA to “administratively resolve” issues of the Food & Drug Amendments Act of 2007.

Representative Bob Latta’s office explained they were under the impression that FDA has not implemented FDAAA regulation of improved pet food ingredient definitions (which was required to be completed in 2009) because of an issue of wording in the law. The issue – as told to me by Rep Latta’s office – is surrounding a few words in the law; (pet food) ingredient standards and (pet food) ingredient definitions. As was explained to me, FDA cannot complete the task (to update pet food ingredient definitions) as the law is written all because of these two words – ‘standards’ and ‘definitions’. Is this correct? It was explained to me FDA has asked Congress to legislatively amend the FDA Amendments Act of 2007 to give clarity to law – to amend the law to state either ‘pet food ingredient definition’ or ‘pet food ingredient standard’ – one or the other phrase, not both.

Association for Truth in Pet Food is asking for FDA clarification. Has the FDA not implemented Sec. 1002 (a) due to these two words causing FDA confusion? Could FDA explain what exactly has stalled the implementation of Sec. 1002 (a) of FDAAA?

Susan Thixton

And much to my surprise, shortly after this email was sent I received a notice from FDA; Dr. Dan McChesney’s would like to speak with us (Association for Truth in Pet Food) on this issue. Our phone conference meeting is scheduled for August 9th.

I don’t know what is going on, but somehow things seem very suspicious to me. It could be nothing, or it could be industry groups are trying to pull a fast one. Facts are: 1) Congress developed laws in 2007 (after the deadliest pet food recall in history) requiring FDA to establish pet food ingredient “standards and definitions”, “processing standards for pet food” and “updated standards for the labeling of pet food”. 2) This was supposed to be completed in 2009. 3) It has not been completed.

Opinion

Meriam-Webster.com defines “standard” as: “something set up and established by authority as a rule for the measure of quantity, weight, extent, value, or quality”.

This is very simple. Congress developed the pet food laws of FDAAA after the deadly 2007 pet food recall. They were trying – legally – to prevent another horrible pet food recall from ever happening again. Melamine contaminated vegetable proteins in 2007 resulted in the deaths and permanent illness of thousands of cats and dogs. How can contamination ever be prevented from happening if pet food ingredients don’t have an established ‘standard’ (something set up and established by FDA authority as a rule for the measure of quality)? How can another deadly recall be prevented if pet food ingredients are not clearly ‘defined’ (expressing the essential nature of the ingredient)? That is what I believe was the intent of Congress in 2007 with FDAAA. Exactly as the law was written. Congress wanted pet food ingredients to have an established standard measure of quality and a clearly defined essential nature of the ingredient. Consumers deserve this. FDA needs to get this done without interference from industry or AAFCO.

An update to this will be posted after our meeting with Dr. McChesney.

(a) PROCESSING AND INGREDIENT STANDARDS.—Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services (referred to in this title as the ‘‘Secretary’’), in consultation with the Association of American Feed Control Officials and other relevant stakeholder groups, including veterinary medical associations, animal health organizations, and pet food manufacturers, shall by regulation establish—

(1) ingredient standards and definitions with respect to pet food;

(2) processing standards for pet food; and

(3) updated standards for the labeling of pet food that include nutritional and ingredient information.

(b) EARLY WARNING SURVEILLANCE SYSTEMS AND NOTIFICATION DURING PET FOOD RECALLS.—Not later than 1 year after the date of the enactment of this Act, the Secretary shall establish an early warning and surveillance system to identify adulteration of the pet food supply and outbreaks of illness associated with pet food. In establishing such system, the Secretary shall—

(1) consider using surveillance and monitoring mechanisms similar to, or in coordination with, those used to monitor human or animal health, such as the Foodborne Diseases Active Surveillance Network (FoodNet) and PulseNet of the Centers for Disease Control and Prevention, the Food Emergency Response Network of the Food and Drug Administration and

the Department of Agriculture, and the National Animal Health Laboratory Network of the Department of Agriculture;

(3) work with the National Companion Animal Surveillance Program, the Health Alert Network, or other notification networks as appropriate to inform veterinarians and relevant stakeholders during any recall of pet food; and

(4) use such information and conduct such other activities as the Secretary deems appropriate.

SEC. 1003. ENSURING EFFICIENT AND EFFECTIVE COMMUNICATIONS DURING A RECALL.

The Secretary shall, during an ongoing recall of human or pet food regulated by the Secretary— (1) work with companies, relevant professional associations, and other organizations to collect and aggregate information pertaining to the recall;

(2) use existing networks of communication, including electronic forms of information dissemination, to enhance the quality and speed of communication with the public; and

(3) post information regarding recalled human and pet foods on the Internet Web site of the Food and Drug Administration in a single location, which shall include a searchable database of recalled human foods and a searchable database of recalled pet foods, that is easily accessed and understood by the public.

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Comments 8

Not a day goes by that we do not have to watch our huge ineffective government agencies waste millions in tax payers dollars. It seems they get paid to take up space and block any movement toward progress.

Another eXample of the corporate power in America having the government do their bidding to the determent of “We the People”. For example the US Chamber of Commerence and various other corporate acronyms of the corporate lobbies is pushing the DOJ to make an employees use of a company computer a felony thru the 2007 Computer Fraud Legislation. And we thought that legislation was for bad guy hackers and those stealing our info- I wonder how many of you are aware that they slipped wording into that bill that say for instance, if you were order something on eBay on your work computer it is now a misdemeanor
Our government hates us and any values we may have- we are a work unit to their benefactors..

Susan, thanks for trying to understand this and follow through on it. From what you’ve written so far, it does seem like a bid by the industry to write their own definitions and standards… the fox guarding the hen house again. Appreciate your work as always shining the light of day on these issues in a public forum.

I am a retired federal agency attorney and practiced administrative law all my career. Congress passes law but then it is the administrative agency, in this case FDA, that has to implement the law by writing regulations governing how the law is defined and administered. Frequently Congress places time limits in the law for implementation but then does not fund the agency with enough money to implement the extra work created by the law. I did not work for FDA, but my guess is that they are seriously understaffed and underfunded, like most agencies. I was working 10 hour days, 6 days a week, and my agency wanted me to come in and work on Sundays also. Instead of having a heart attack from work, I retired. I don’t think the delay is the FDA’s fault, it is probably due to the cut backs from Congress, particularly the sequestration. That being said, the FDA accepts comments on proposed regulations from everyone, industry groups as well as individuals. I think the problem is with the wording in the law Congress passed. It is not written very well and their choice of wording, ingredient standard, leads to confusion, which the FDA must sort out. The wording implies that there is an ingredient standard, which does not really exist under the law. Hopefully, the FDA will not cave and accept what industry wants. It is good that they hear from consumers and concerned pet owners as well.

Without wishing to sound arbitrary or capricious, this matter is an issue of priority within the FDA. The FDA Administrator sets the priority. If this problem was a top priority, the Administrator would use existing resources (time, money and people) to produce the solution. Whether underfunded and or understaffed does not negate the fact that we are still waiting for the fix. The FDA has failed to produce the solution regarding pet food standards and pet food ingredient definitions and this is particularly egregious when one takes into consideration the Act was passed in September 07 and the FDA had until Sep 09 to complete. We would all do ourselves well by contacting our elected representatives and ask them to get involved with producing a solution this to problem.

This jumped out at me:
“AAFCO strongly supports this legislative effort and urges your support as well. Otherwise, the development and introduction of new feed ingredients to the marketplace will become even more burdensome and likely jeopardize AAFCO’s production of its OP.”

It suggests that feed ingredients under development and introduction (like feathers, GMO, higher antibiotic levels, who knows what else for example) are perhaps being delayed from marketing by the lack of clarity or conflicting language surrounding standards and ingredients. The legislative fix is certain to pave the way forward for the feed industry to increase profits with their “innovations”, likely to the detriment of the consumer and pet. The legislative fix is also likely to limit the corporate liability from any future harm caused by the feed ingredients. It will have to be closely read and monitored thru the legislative process to prevent last minute changes from being added.